Transvaginal Mesh TVT Sling Procedure

Transvaginal Mesh TVT Sling Procedure
Transvaginal mesh lawsuits have been filed against a variety of companies that make the medical devices, alleging they suffered from transvaginal mesh complications. Among transvaginal mesh side effects and complications are mesh erosion, infection, pelvic pain and urinary problems. Some transvaginal mesh lawsuits have resulted in settlements or awards for the plaintiffs.

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Transvaginal Mesh Lawsuits

Thousands of lawsuits have been filed against the makers of transvaginal mesh devices alleging the medical devices were defectively designed and caused serious health problems. The meshes are implanted to treat pelvic organ prolapse or stress urinary incontinence, but have been linked to mesh erosion, organ damage, chronic pain, bowel and bladder perforation, vaginal scarring, urinary problems and infections.

Some women have undergone surgery to remove the vaginal mesh, but in some cases the damage has allegedly been permanent. In addition to surgery, treatment of complications associated with the mesh can include IV therapy, blood transfusions and drainage of hematomas or abscesses.

As of November 2014, more than 65,000 transvaginal mesh lawsuits had been filed against a number of manufacturers, including C.R. Bard, Ethicon (a Johnson & Johnson subsidiary), American Medical Systems and Boston Scientific and consolidated for pretrial proceedings. Some lawsuits have been settled or resulted in awards to the plaintiffs, but many lawsuits are still pending.

According to the U.S. Judicial Panel on Multidistrict Litigation in a report from November 17, 2014, US District Judge Joseph Goodwin is currently overseeing approximately 10,000 lawsuits against C.R. Bard; 18,000 lawsuits against American Medical Systems; 14,000 lawsuits against Boston Scientific; 22,000 lawsuits against Ethicon; 1,700 lawsuits against Coloplast; 250 lawsuits against Cook Medical; and 70 lawsuits against Neomedic.

Transvaginal Mesh Complication

SUI typically occurs in women after childbirth and/or pregnancy: Due to muscle weakness in the pelvic area, urine leaks from the body during activities such as coughing, laughing, exercising, etc. POP, known as Cystourethrocele, typically occurs in older women whose muscle and tissue groups in the uterus, bladder and pelvic region have become stretched and weakened. As well, women have an increased risk of developing POP with menopause and hysterectomy.

Vaginal sling surgery is supposed to strengthen the internal organs and prevent them from coming into contact with each other by implanting mesh tape.

Since 2005 more than 1,000 TVT sling complaints from nine different manufacturers have been reported to the FDA, which culminated in a FDA safety alert in 2008 about serious complications associated with the use of mesh products--also known as pelvic or vaginal mesh and bladder slings-- in treatment of SUI and POP. A number of women have undergone surgeries to have the mesh removed. In 2009 the FDA issued another FDA safety alert. According to the FDA, about 1,500 reports were filed between 2008 and 2010.

In January 2012, the FDA ordered the makers of transvaginal surgical mesh products to study the risks associated with the products. The order came following the recommendation of an FDA advisory panel in September 2011. According to the FDA, between 2008 and 2010 the number of adverse events reports to the FDA about transvaginal meshes increased five times. Not all surgical mesh products are affected by the FDA's order; those that are implanted through the abdomen are not included.

In July 2011, the FDA warned that transvaginal placement of surgical mesh to treat pelvic organ prolapse may carry more risks than other surgical options, without any evidence of greater benefit. The agency stressed that this warning warning does not apply to mesh placed abdominally, or to treatment for stress urinary incontinence. An advisory committee will be meeting in September 2011 to discuss the safety and efficacy of the mesh products in those indications.

Before TVT slings were approved, POP and SUI were treated without mesh in a procedure called an abdominal sacrocpopexy, which uses the patient's own ligaments to support weakened muscles. Now, polypropylene mesh is woven through pelvic tissue and placed underneath the urethra, creating a support sling. The tape is designed to support the urethra when pressure is exerted. However, TVT lawsuits claim that many of the transvaginal mesh products have not met reasonable safety standards and that the manufacturers failed to warn of significant risks. Some experts believe the mesh to be a defective design (the Mentor O.B Tape vaginal sling was removed from the market due to a design defect) and that complications develop because it prevents surrounding tissue to receive nutrients. As well, the mesh can erode into the vagina, migrate or shrink, which results in urinary problems, pelvic pain, and infections.

In The Journal Obstetrics & Gynecology (Oct 2005), safety reviewers found that more than 15 percent of the patients who received the mesh experienced erosion, which often results in pain and infections. The study concluded that Surgeons should be aware of the potential complications of synthetic meshes. Until data on the safety and efficacy of the intravaginal slingplasties are available, these procedures cannot be recommended.

Some women have undergone additional surgical procedures, often to remove the mesh, along with IV therapy, blood transfusions, and drainage of hematomas or abscesses.

Transvaginal Mesh Lawsuits by Manufacturer

C.R. Bard

C.R. Bard currently faces around 10,000 lawsuits consolidated for pretrial proceedings in US district court before Judge Goodwin. Lawsuits filed against Bard involve the Avaulta transvaginal mesh.

Ethicon/Johnson & Johnson

Johnson & Johnson subsidiary, Ethicon faces approximately 22,000 lawsuits consolidated for pretrial proceedings. Ethicon makes the Gyncare mesh products. In early 2014, Ethicon came under fire for negligently destroying thousands of documents related to the development of some of its vaginal mesh products.

American Medical Systems

American Medical Systems faces approximately 18,000 lawsuits consolidated for pretrial proceedings in US district court before Judge Goodwin.

Boston Scientific

Boston Scientific currently faces approximately 14,000 lawsuits consolidated for pretrial proceedings in US District Court before Judge Goodwin.

Some Boston Scientific lawsuits have gone to trial. The first federal bellwether trial to go to court resulted in an $18.5 million award to four women who filed lawsuits against the company. The award was announced in November 2014. The previous month saw an award of $26.7 million against Boston Scientific regarding its Pinnacle mesh device. In September 2014, a $73.4 million award was given to plaintiffs who filed a lawsuit concerning Boston Scientific's Obtryx device.

Tissue Fixation System (TFS)

Lawsuits have been filed against Tissue Fixation System (TFS), a pelvic mesh tape that is used to treat Pelvic Organ Prolapse (POP). The lawsuits allege that TFS Manufacturing Pty and TFS Surgical (US) aggressively marketed their Tensioned Mini-Sling with Anchors while exaggerating the product's safety.

Transvaginal Mesh Legal Help

If you or a loved one has suffered damages in a Transvaginal Mesh case, please click the link below and your complaint will be sent to a Medical Device lawyer who may evaluate your claim at no cost or obligation.

TRANSVAGINAL MESH LEGAL ARTICLES AND INTERVIEWS

Winnipeg, Canada Christine Asprey’s life went from active and full to an emotional, physical and financial nightmare. All this after what was supposed to be a routine fix with Johnson & Johnson (J & J) transvaginal mesh to solve some minor issues with bladder control [READ MORE]

York, PA: “A good number of attorneys have reported transvaginal mesh adverse events to the FDA on behalf of their clients/patients, but over 23,000 reports are from physicians,” says Madris Tomes, founder of Device Events and former FDA Program Manager. “Physicians are not great at reporting— this is a HUGE number. [READ MORE]

Seattle, WA: Transvaginal mesh problems are no respecter of borders, in that Canadian women are having just as many problems with transvaginal mesh complications as those in the US. In spite of the fact Canada has a much lower population overall than the US, there are still tens of thousands of women having undergone TVT sling and transvaginal mesh procedures, with hundreds more having filed lawsuits alleging problems with the devices [READ MORE]

READER COMMENTS

Posted bysouth carolina
on November 3, 2015

most of you are lucky i cant find a dr to do anything i have constant pain i take medication for pain and to relax my bladder but nothing is wrong right. The doc that put mine in waited just long enough laughed and told me to sue him and quit treating me. No one else will go behind him because they dont see it as life threatening yet. But they dont feel the pain Im in on a daily basis

Posted byDebbie J
on November 1, 2015

Ladies,
The hideous head scratcher:
Regardless of the manufacturer's name, the multiple injuries, the suffering of the women involved with these class action monetary awards.... We each will be lucky to be paid $50 or less... someday.
One more slap in the face.

Posted byMissouri
on October 28, 2015

Pelvic pain frequent burning throbbing intense hot flashes not to mention no intercourse because of pain and they wanna send me to a gynacologists who knows nothing of repairing the damage thats done. No doctors in St. Louis area know how to fix the problem. And yet no date set for trial hummmm makes me wonder whats going on what`s the holdup Ethicon??? You destroyed records you knew would help us. We are the victims here while you keep getting a slap on the wrist and keep producing products that don`t work. You should be shamed and I can`t wait for my date in court with you all.

Posted byshawn C.
on October 13, 2015

I had mesh put in during a hysterectomy in 2003. I have had nothing but problems ever since! I dont know what has been worse, the daily pain that makes life so hard that if I didnt have my kids and husband I honestly would rather die ! OR that since complications from the first surgery back in 03 led to severl more surgeries over just the next few weeks that at the age of 30, having never before even taking 1 pain pill in my life, i became addicted to pain pills which led to severe opiate addiction. I tried , unseccesfully for years to get help for addiction and now am a heroin addict. I have been to jail and am currently on probation. Before this I owned my own business and was a single mother doing very well taking care of myself and kids. Now I am looked at as a no good , loser drug addict. And to add insult to injury I have begged for help from my doctors but no matter how bad my pain is and how permanent it is, NONE of my doctors will help me with any pain managment so im left with no choice but to self medicate. Please dont judge me, I have tried and still trying to get help the right way and am having my next surgery in 2 weeks. I have had 2 open wounds in pelvic area where mesh is hanging out of my body for 2 years now that drain infection and urine 24 hours a day. I have 2 holes in my urethria that doctors said they cannot fix EVER that I will leak pee forever. I have constant UTIs. I have not slept well in 10 years because all night every night even if I do fall asleep, I wake up 1 to 2 times at a minimum to pee. No sleep = terrible days! I could go on and on listing the pain and the problems from this mesh both physical and emotional but I think I got my point across. This mesh has definatly made my life a NIGHTMARE!!!

Posted byLori
on October 2, 2015

To all comments,
I was told that no other specialist but a Urogynecologist should be messing with the mesh. Not all specialist are trained to remove this type of mesh and since it has decided to became a part of us. It needs to be treated with kid gloves.
I have heard of one of these specialist in the Orlando florida area that Im looking at very closely to get mine removed, but Im gun shy so I will be doing a lot of research!
Thanks FDA for making our lives like a living hell! You knew there was not enough research being done on this and you put it out anyway! And still have it out on the shelves with a warning label??? REALLY!!!!
The manufactures should just have the same surgery as ours being told as they told the doctors how great it is and will make like so easier and see what hell they have to live with.
Better yet just ask them if they would put one inside their body! I guarantee you they would say no!!!

Posted byLA. Wife
on September 27, 2015

After having my 3rd son I fought incontinence for a couple of years, always peeing on myself in most all circumstances. My relationship with my husband suffered because I was always concerned about a possible smell so I decided to have the sling surgery, I was given NO warnings just a simple surgery well after that my problems only got worst and over the following year the sling started to prolapse severely. I could not even think about intercourse and still had to wear a pad all the time. well I had to have corrective surgery and when did they replaced that sling with another recalled one and it did the same with even worst side effects. I suffered, my family suffered, my career as a nurse suffered, my kids suffered. until I had to have another surgery to fix the last one and since then for the pas t3 years I have been better. This has been the worst years of my family's life and my pain is put behind me now.

After that surgery, I had so many problems. I never stopped bleeding. I was bleeding through my rectum, I always hurt during sex. I kept having to go back to Dr S because there was one place that she kept saying that just would not heal. She would cauterize it. Finally after about 1 1/2 I finally went to another Dr because it seemed I just was not getting any help from her. This new Dr removed it right away. That was in I think 2009/2010.

To this day I still bleed from a spot that has not healed. I have over the yrs had that same spot cauterized to no avail. I was told last year there isn't any skin in that area left to cauterized. I made an appt last week with another Dr, she said she think she sees a piece of mesh still left, so I have an appt for next month set up to have it looked at. So this has been going on for 7 yrs.

Posted byAnonymous
on March 31, 2015

I was very upset to know a Doctor would gut me open and poison my body . As a mother of 3, 1 grand daughter and a wonderful marriage of 25 years I wish this had Never happened. And now to learn that a judge of the United States of America has be Ignored by Billion Dollar Coporations that payed Doctors to Slaughter my body as if I was a test dummies, better yet a Guinea Pig for profit is a Crime. Not Only the Doctors ,but the CEO's, Head of FDA , and lets not forget Hospitals , should be Prosecuted and send the prison . The law states that when a Crime has been committed and you are found guilty then you go to prison or executed. Because Billions of dollars are on hand then it's an excuse to comment a crime . Well 5 .7 million is not by any means enough per women to cover up a excuse of this Size. These Corporation have billions in insurance to cover lawsuits of this statue. Attorneys need to stop pretending this is not a major problem. The asbestos and cigarettes lawsuits slaughtered people live their's no difference. I want 1 Billion Dollars from Johnson and Johnson (ethicon) , The Hospital, The Doctors and Medical Association and their Administration, The Polypropylene maker that decided to design such a product (knowing) it was never meant for a human because the way it was designed. The Investors that believed in this lie. And Last but not lest The United State Government . You all (know)willingly Vaginal Mesh products was a Hindus Crime .And you All have to Pay in full. Remember What Goes Around Comes Around. Do unto others as you would have them to do unto you. Your Time is Up !!!!

Posted byIllinois
on March 26, 2015

Mesh erosion and issues with intercourse.

Posted byGeorgia
on February 6, 2015

I have been suffering from serve UTIs for a long time. I have recently had three in the past two months. My doctor is now refering me to a urologist to have this checked out to see if it is the mesh sling.

Posted byAnonymous
on January 18, 2015

I HAD THE TRANSVAGINAL MESH SLING INSERTED IN 2005, AND WAS NEVER TOLD OF ANY RISKS. IT HAS BEEN 9 YEARS, AND NOW THE MESH HAS EMBEDDED ITSELF IN MY PUBIC BONE, CAUSING INFLAMMATIN AND SEVERE PAIN. I HAVE HAD STEROIID INJECTIONS AND ALSO TAKE PAIN KILLERS.
\MY MESH SLING WAS MADE BY JOHNSON&JOHNSON, THEY SHOULD BE HELD ACCOUNTABLE FOR RUINGING THE LIVES OF THOUSANDS OF WOMEN. FROM WHAT I UNDERSTAND THE CEO'S OF THIS COMPANY WERE AWARE OF THE RISKS INVOLVED IN THIS MESH BUT PUT IT ON THE MARKET ANYWAY.

Posted byAnonymous
on December 6, 2014

i had a hysterectomy in June 05. I have slight incontinence and the recommended a mesh sling. A year later i would wake up with a burning pain in my pelvic area, then i started getting bladder infections. A cystoscopy was done, the urologist insisted nothing was wrong with the sling. Xrays now show the mesh has embedded itself in my pubic bone and it would be impossible to remove. I have pelvic pain daily, take pain medicine and am getting steroid injections.
This has been an emotional and physical nightmare. it is the biggest regret of my life because it cannot be undone, it will be a problem the rest of my life. The FDA should not allow such a high risk device to be put in the human body, anyone who has the sling is never out of danger.

Posted byAnonymous
on August 22, 2014

In 2006 I had a partial hysterectomy & a bladder sling put in. I had to have emergency surgery the next day for bleeding out. I was sent home 3 days later. I started having severe pain 4. Days later, I was rushed to the emergency room & admitted, they did all kind of year tests including ct scans everyday which looked like trash bags filled with air then tied into knots. I was then flown to BJC in St. Louis, 12 hours later they. Were rushing me to surgery, breathing for me, after 16 hours in the o.r., they told my husband they had no excuse as to why I was still alive. I lost all but 14 1\2 " of. Intestines, I'm now permanently. On TPN to feed me and keep me alive this is all because of organ prolapse from NY bladder along I had put in in 06. Don't get this surgery it will ruin your life, it sure did mine.

Posted byAnonymous
on May 13, 2014

My life has begin too fall apart. I walk with a cane. I have no collagen lefted in my stomach. Everyday I wish I could Died. Vaginal mesh is the worst product know to the human race. The FDA ALLOWED THIS TO HAPPEN. THE FDA SHOULD BE SUED!!!!!

Posted byIllinois
on March 14, 2014

I have had lower pain/discomfort in my abdomen ever since I had the mesh/sling, just always thought it was normal...didn't realize it wasn't until a friend saw the add on TV and told me that I should check into this.

Posted byOntario
on September 27, 2013

I have constant discomfort in the lower abdomen and lower back, and part of the mesh has torn away and caused a hole in my cervix. I am now scheduled for surgery to remove the exposed mesh and repair the hole, hopefully. Have been told that ongoing problems may occur.

Posted byWest Virginia
on October 2, 2012

There is unremitting pain in the area of my urethra. This pain limits the sexual act between my husband and me, prevents me from walking, riding a bike, or just sitting comfortably. There has also been constant bloody discharge from the area around my urethra.

Posted byCalifornia
on August 7, 2012

No sex since surgery in 2005 (too painful), therefore, no relationships. Leakage, urgency, slow stream, UTI's, bladder infections, trouble emptying, discharge/infections, pain when sitting or walking at times. My doctor said that the type of mesh I received cannot be removed.

Posted byBritish Columbia
on October 11, 2011

cutting excrutiating pain when standing and walking, couldn't void so had to self catheterize until 4 months after procedure when mesh had eroded through the urethra making it impossible to thread catheter, have not been able to have sex with husband since procedure 7 years ago.

If I am not taking an antibiotic on a daily basis, I will develop a urinary tract infection. Have had a second surgery to loosen the tape because it prevents me from being able to empty my bladder. Second surgery was unsuccessful so I am scheduled to see a specialist at MUSC on August 17th to determine a new course of action, which may include removal of the sling.

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